Who is sponsoring NCT01487265?

NCT01487265 is sponsored by SCRI Development Innovations, LLC.

What condition does NCT01487265 study?

NCT01487265 studies Non Small Cell Lung Cancer.

What drugs are being tested in NCT01487265?

Interventions: BKM120 and Erlotinib.

What is the status of NCT01487265?

NCT01487265 is currently COMPLETED.

Last reviewed 2019-02-25 · How we verify

Phase II Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib

NCT01487265 Phase 2 COMPLETED Results posted

Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth inhibition and enhancing the response to erlotinib.

Details

Lead sponsor	SCRI Development Innovations, LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	37
Start date	2014-03
Completion	2017-12-11

Conditions

Non Small Cell Lung Cancer

Interventions

BKM120 and Erlotinib

Primary outcomes

Progression Free Survival at 3 Months — 3 months
Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.

Countries

United States